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Amgen gets CHMP negative opinion for Vectibix marketing authorization application

Amgen has got negative opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its application for extending the marketing authorization of Vectibix (panitumumab) in Europe in conjunction with chemotherapy to treat patients suffering from wild-type KRAS metastatic colorectal cancer (mCRC).

Vectibix is the first fully human anti-EGFR antibody approved by the US Food and Drug Administration (FDA) for the treatment of mCRC.

Amgen will review CHMP’s decision and will decide the next steps to be taken in support of the application, as it believes that Vectibix combined with chemotherapy offers an important treatment option for mCRC patients.